Tracheal stent

ABSTRACT

Tracheal stents may include a plurality of wave form structures each extending radially about the support structure, a plurality of axial loop members extending axially between adjacent wave form structures and a polymeric covering disposed thereover. Tracheal stents may include an expandable metal structure and a plurality of spacer fins extending above an outer surface of the expandable metal structure. The plurality of spacer fins may be formed of a material different than that of the expandable metal structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/268,659, filed Feb. 6, 2019, which is a continuation of U.S.application Ser. No. 14/932,407, filed Nov. 4, 2015, which claimspriority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No.62/076,181, filed Nov. 6, 2014, the entirety of which is incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing medical devices. More particularly, the present disclosurepertains to endoprostheses such as tracheal stents.

BACKGROUND

An endoprosthesis may be configured to be positioned in a body lumen fora variety of medical applications. For example, an endoprosthesis may beused to treat a stenosis in a blood vessel, used to maintain a fluidopening or pathway in the vascular, urinary, biliary, tracheobronchial,esophageal or renal tracts, or to position a device such as anartificial valve or filter within a body lumen, in some instances. Bareor partially covered endoprostheses allow tissue ingrowth through thestructure of the endoprosthesis to prevent migration of theendoprosthesis. However, if it is desired to remove the endoprosthesisat some later time, the ingrown tissue must be cut away, causingsignificant trauma to the body lumen. Fully covered stents, on the otherhand, prevent tissue ingrowth to facilitate removal. However, fullycovered endoprostheses are prone to migrate through the body lumen.

Accordingly, it is desirable to provide endoprostheses that exhibitanti-migration features, while reducing the trauma to the body lumen ofthe patient if removal of the endoprosthesis is desired.

BRIEF SUMMARY

The disclosure is directed to several alternative designs, materials andmethods of manufacturing medical device structures and assemblies, anduses thereof.

In one example, a medical stent, such as a tracheal stent, extends froma first end to a second end and includes a support structure extendingfrom the first end to the second end. The support structure includes aplurality of wave form structures each extending circumferentially aboutthe support structure and a plurality of axial loop members extendingaxially between adjacent wave form structures and a polymeric coveringdisposed over the support structure. At least some of the plurality ofaxial loop members are configured to include an extended configurationin which the at least some of the plurality of axial loop members extendradially outward from an outer surface defined by the plurality of waveform structures.

Alternatively, or additionally, at least some of the wave formstructures extend circumferentially about 360 degrees about the supportstructure and form closed rings.

Alternatively, or additionally, at least some of the wave formstructures include a nickel-titanium alloy.

Alternatively, or additionally, at least some of the wave formstructures are formed from nitinol wire.

Alternatively, or additionally, at least some of the wave structures aredefined by a wire diameter that is in the range of about 0.2 millimeters(mm) to about 0.5 mm. Alternatively, or additionally, at least some ofthe wave form structures are defined by a wave frequency in the range ofabout 0.5 to about 4 waves per centimeter (cm) and a wave amplitude inthe range of about 0.25 cm to about 1 cm.

Alternatively, or additionally, at least some of the plurality of axialloop members extend from a peak, a valley or a transition region of awave form structure of the plurality of wave form structures to a peak,a valley or a transition region of an adjacent wave form structure ofthe plurality of wave form structures.

Alternatively, or additionally, the plurality of axial loop membersprovide the only direct connection between adjacent wave form structuresof the plurality of wave form structures.

In another example, a support structure for an endoprosthesis has afirst end, a second end and a lumen extending therebetween. The supportstructure includes a first wave form structure extendingcircumferentially about the support structure and defining a firstclosed ring, the first wave form structure formed of a first wireoscillating in a wave form having a first wave frequency and a firstwave amplitude. The support structure includes a second wave formstructure extending circumferentially about the support structure anddefining a second closed ring, the second wave form structure formed ofa second wire oscillating in a wave form having a second wave frequencyand a second wave amplitude. An axial loop member extends from the firstwave form structure to the second wave form structure and provides aconnection between the first wave form structure and the second waveform structure and is configured to include an extended configuration inwhich the axial loop member extends radially outward from an outersurface defined by the first and second wave form structures.

Alternatively, or additionally, the first wave form structure and thesecond wave form structure are formed from nitinol wire.

Alternatively, or additionally, at least some of the wave structures aredefined by a wire diameter that is in the range of about 0.2 mm to about0.5 mm.

Alternatively, or additionally, at least some of the wave formstructures are defined by a wave frequency in the range of about 0.5 toabout 4 waves per cm and a wave amplitude in the range of about 0.25 cmto about 1 cm.

Alternatively, or additionally, in another example, the axial loopmember extends from a peak, a valley or a transition region of the firstwave form structure to a peak, a valley or a transition region of thesecond wave form structure.

In another example, a method of forming a support structure for anendoprosthesis having a first end, a second end and a lumen extendingtherebetween includes forming a first wave form structure from a firstwire, the first wave form structure undulating side to side whileextending circumferentially around to form a first closed ring. A secondwave form structure is formed from a second wire, the second wave formstructure undulating side to side while extending circumferentiallyaround to form a second closed ring. An axial loop member having a firstend and a second end is secured, the first end secured to the first waveform structure and the second end secured to the second wave formstructure.

Alternatively, or additionally, the first wave form structure is formedon a mandrel.

Alternatively, or additionally, the second wave form structure is formedon a mandrel.

Alternatively, or additionally, the method further includes forming aplurality of additional wave form structures from a plurality of wires,each of the plurality of additional wave form structures undulating sideto side while extending circumferentially around to form a plurality ofadditional closed rings.

Alternatively, or additionally, the method further includes securing aplurality of axial loop members between adjacent wave form structures ofthe plurality of additional wave form structures.

Alternatively, or additionally, the first wire and the second wireinclude a nitinol wire.

Alternatively, or additionally, the first end of the axial loop memberis secured to the first wave form structure via welding.

In another example, a medical stent, such as a tracheal stent, extendingfrom a distal end to a proximal end includes an expandable metalstructure extending from the distal end to the proximal end, theexpandable metal structure convertible between a compressedconfiguration for delivery and an expanded configuration once deployed,the expandable metal structure including an inner surface defining astent lumen and an outer surface. A plurality of spacer fins extendsabove the outer surface of the expandable metal structure and are formedof a material different than that of the expandable metal structure.

Alternatively, or additionally, the plurality of spacer fins are formedof a biodegradable or bioabsorbable material.

Alternatively, or additionally, the plurality of spacer fins are formedfrom a filament that is interlaced within the expandable metalstructure.

Alternatively, or additionally, the plurality of spacer fins areseparately formed each having an end, and the ends of the plurality ofspacer fins are encapsulated in a polymeric coating that is disposedover the expandable metal structure.

Alternatively, or additionally, the plurality of spacer fins include acap secured to high spots formed within the expandable metal structure.

Alternatively, or additionally, at least some of the plurality of spacerfins are triangular in shape, with a base secured relative to theexpandable metal structure and an apex extending above the base.

Alternatively, or additionally, the expandable metal structure comprisesa laser cut expandable metal structure.

Alternatively, or additionally, the expandable metal structure includesa woven or braided expandable metal structure.

In another example, a medical stent, such as a tracheal stent, extendingfrom a distal end to a proximal end includes an expandable metalstructure extending from the distal end to the proximal end, theexpandable metal structure convertible between a compressedconfiguration for delivery and an expanded configuration once deployed,the expandable metal structure including an inner surface defining astent lumen and an outer surface. A biodegradable filament is interwoventhrough the expandable metal structure to form a plurality ofbiodegradable spacer fins extending above the outer surface of theexpandable metal structure.

Alternatively, or additionally, the expandable metal structure includesa laser cut expandable metal structure.

Alternatively, or additionally, the expandable metal structure includesa woven or braided expandable metal structure.

Alternatively, or additionally, the biodegradable filament includessquare or round shaped protruding caps.

Alternatively, or additionally, the biodegradable filament has adiameter in the range of about 0.1 cm to about 1 cm.

Alternatively, or additionally, at least some of the plurality of spacerfins are triangular in shape.

In another example, a medical stent, such as a tracheal stent, extendingfrom a distal end to a proximal end includes an expandable metalstructure extending from the distal end to the proximal end, theexpandable metal structure convertible between a compressedconfiguration for delivery and an expanded configuration once deployed,the expandable metal structure including an inner surface defining astent lumen and an outer surface. A polymeric coating is disposed overthe expandable metal structure and a plurality of biodegradable spacerfins are secured relative to the polymeric coating, the plurality ofbiodegradable spacer fins extending above the outer surface of theexpandable metal structure.

Alternatively, or additionally, at least some of the plurality of spacerfins are triangular in shape, with a base secured relative to theexpandable metal structure and an apex extending above the base.

Alternatively, or additionally, the plurality of biodegradable spacerfins are separately formed each having an end, and the ends of theplurality of biodegradable spacer fins are encapsulated in the polymericcoating.

Alternatively, or additionally, the plurality of biodegradable spacerfins are formed of a biodegradable material comprising poly-l-lactideacid (PLLA) and/or poly(lactide-co-Glycoside 8515) (PLGA 8515).

Alternatively, or additionally, the plurality of biodegradable spacerfins have an average height, relative to the outer surface of theexpandable metal structure, ranging from about 0.1 cm to about 0.5 cm.

Alternatively, or additionally, the polymeric coating includes silicone.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be further understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 is a schematic illustration of a patient, showing a trachea stentdisposed within the patient's right main bronchus in accordance with anembodiment of the disclosure;

FIG. 2 is an illustration of a trachea stent in accordance with anembodiment of the disclosure;

FIG. 3 is a schematic illustration of a portion of the trachea stent ofFIG. 2 in accordance with an embodiment of the disclosure;

FIG. 4 is a schematic illustration of a portion of the trachea stent ofFIG. 2 in accordance with an embodiment of the disclosure;

FIG. 5 is a perspective illustration of a trachea stent in accordancewith an embodiment of the disclosure;

FIG. 6 is a schematic cross-sectional illustration of the trachea stentof FIG. 5 in accordance with an embodiment of the disclosure;

FIG. 7 is a schematic illustration of a portion of a trachea stent inaccordance with an embodiment of the disclosure; and

FIG. 8 is a schematic cross-sectional illustration of a portion of atrachea stent in accordance with an embodiment of the disclosure.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the disclosure. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment. It will be appreciated that while the disclosure describesan airway or trachea stent, the features and elements described hereinmay be applied to any variety of endoprosthesis.

FIG. 1 provides a schematic illustration of the torso of a patient 10.The patient 10 includes a trachea 12, a left main bronchus 14 and aright main bronchus 16 (relative to the patient's perspective). Anendoprosthesis 18 may be seen in phantom, disposed within the right mainbronchus 16. It will be appreciated that this placement is merely forillustrative purposes, as the endoprosthesis 18 may be deployedelsewhere in the trachea 12 or even down into the bronchia (notillustrated). It will also be appreciated that while the endoprosthesis18 is described herein as an airway stent, the endoprosthesis 18 may bedeployed in a variety of other bodily lumens, including but not limitedto the vascular, urinary, biliary, tracheobronchial, esophageal or renaltracts. Although illustrated as a stent, the endoprosthesis 10 may beany of a number of devices that may be introduced endoscopically,subcutaneously, percutaneously or surgically to be positioned within anorgan, tissue, or lumen, such as a heart, artery, vein, urethra,esophagus, trachea, bronchus, bile duct, or the like.

A difficulty in placing an endoprosthesis in the trachea 12 is that thepatient 10 may have a tendency to try and cough out the endoprosthesis18. The human respiratory system is designed, when encountering anobstacle or other foreign object, to try to move the obstacle out of theway. This may mean pushing the object farther down, to a position ofrelative safety. This may also mean trying to cough it out. The humanbody may try to forcibly eject the object. Accordingly, and in someembodiments, the endoprosthesis 18 may be configured to help hold theendoprosthesis 18 in place within the trachea 12.

Another difficulty in placing an endoprosthesis in the trachea 12 isthat the presence of a foreign object such as an endoprosthesis triggersan inflammatory response that produces mucus. Mucus can become trappedbetween the body of an endoprosthesis and the wall of the trachea 12.Trapped mucus can stimulate or facilitate the growth of bacteria.Accordingly, and in some embodiments, the endoprosthesis 18 may beconfigured to provide air channels or voids by spacing at least a partof the endoprosthesis 18 away from the wall of the trachea 12.

FIG. 2 provides an illustration of a trachea stent 20 that may bedeployed as shown with respect to the endoprosthesis 18 of FIG. 1. InFIG. 2, the trachea stent 20 is shown on a mandrel 30. The trachea stent20 may include a support structure 22 extending from a first end 24 to asecond end 26. The support structure 22 may include one or more (aplurality are illustrated) wave form structures 28 that extendcircumferentially about the support structure 22. In some embodiments,the wave form structures 28 extend about 360 degrees about the supportstructure 22 and thus each of the wave form structures 28 may formclosed loops. In some embodiments, each wave form structure 28 is formedindependently of any other wave form structure 28. The wave formstructures 28 may be arranged axially adjacent one another along thelength of the support structure 22. In some embodiments, each wave formstructure 28 may be formed on the mandrel 30, by forming a wire into thesinusoidal pattern shown, having peaks oriented toward the first end 24of the support structure 22 and valleys oriented toward the second end26 of the support structure 22.

The wave form structures 28 are joined together via connectors, such asone or more axial loop members 32. In some embodiments, the axial loopmembers 32 (two are illustrated in FIG. 2) are the only physicalconnection between adjacent wave form structures 28. It will beappreciated that, while not illustrated, the trachea stent 20 mayinclude a polymeric coating or covering to prevent tissue ingrowth intothe interior of the trachea stent 20. The polymeric coating or covering,if present, may be disposed about an exterior of the support structure22, for example. The axial loop members 32 are shown in an extendedconfiguration in which they extend radially outward from an outersurface 34 that is defined by the wave form structures 28 and thepolymeric coating or covering, if present. While not illustrated, itwill be appreciated that the support structure 22 may have a compressedconfiguration for delivery in which the axial loop members 32 flattenagainst the outer surface 34.

The connectors or axial loop members 32 may be configured to engage awall of a body lumen in the expanded state to inhibit migration of theendoprosthesis 18 subsequent to implanting the endoprosthesis 18 in thebody lumen. For example, the connectors or axial loop members 32 mayengage the tissue between cartilage rings within the tracheal anatomy toprovide anti-migration support for the endoprosthesis 18.

A space or opening may be defined between the connectors or axial loopmember 32 and the outer circumference of the wave form structures 28and/or overlaying polymeric coating or covering as viewed along thecentral longitudinal axis of the support structure 22, as a result ofthe connectors or axial loop members 32 extending radially outward of orabove the outer circumference of the wave form structures 28 and/oroverlaying polymeric coating or covering. The space or opening may beunobstructed by any other structure of the endoprosthesis 18.Accordingly, tissue ingrowth through these spaces or openings subsequentto implanting the endoprosthesis 18 may further secure theendoprosthesis 18 in place in the anatomy and prevent migration of theendoprosthesis 18.

The support structure 22 may be formed of any suitable material. In someembodiments, the support structure 22 may be formed of a nickel-titaniumalloy such as nitinol. In some embodiments, at least some of the waveform structures 28 may be formed of a nitinol or other wire having awire diameter that is in the range of about 0.2 mm to about 0.5 mm. Insome embodiments, at least some of the axial loop members 32 may beformed of a nitinol or other wire having a wire diameter that is in therange of about 0.25 mm to about 0.4 mm, which may be the same ordifferent from the wire diameter used to form at least some of the waveform structures 28.

FIG. 3 provides an illustration of a portion of a wave form structure28. In some embodiments, at least some of the wave form structures 28may be considered as undulating back and forth in a sinusoidal pattern.A sinusoidal pattern may be defined, at least in part, by a frequencyand an amplitude. As illustrated, the wave form structure 28 may beconsidered as having a frequency that is in the range of about 0.5 toabout 4 waves per cm. A wave may be defined as the distance orwavelength F between adjacent peaks. The wave form structure 28 may beconsidered as having an amplitude A, measured as the distance betweenpeak and valley. In this, it will be appreciated that peaks and valleysare a matter of perspective. What appears as a peak from one side lookslike a valley if viewing from the opposite side.

FIG. 4 provides an illustration of two adjacent wave form structures 28.One of the wave form structures (i.e., the first wave form structure) islabeled as 28 a and the adjacent wave form structure (i.e., the secondwave form structure) is labeled as 28 b. To avoid confusion, each waveform structure 28 a, 28 b are labeled as having peaks P and valleys V.It will be appreciated that in connecting the axial loop members 32 toadjacent wave form structures 28, there are a variety of differentrelative locations at which the axial loop members 32 may be connected.Each axial loop member 32 may be considered as having a first end 36connected to the first wave form structure 28 a and a second end 38connected to the adjacent second wave form structure 28 b.

In FIG. 4, an axial loop member 32 a is shown having its first end 36secured to a peak P on the wave form structure 28 a and its second end38 secured to a peak P on the wave form structure 28 b. An axial loopmember 32 b is shown extending from an intermediate position I on thewave form structure 28 a to an intermediate position I on the wave formstructure 28 b. An axial loop member 32 c is shown extending from avalley V on the wave form structure 28 a to a valley V on the wave formstructure 28 b. An axial loop member 32 d is shown extending from a peakP on the wave form structure 28 a to a valley V on the wave formstructure 28 b. It will be appreciated that these axial loop members 32a, 32 b, 32 c and 32 d, are illustrative only, and are intended merelyto illustrate the variety of available connection points. In alternativeembodiments, the first end 36 of the axial loop member 32 may be securedat any desired location along the first wave form structure 28 a whilethe second end 38 of the axial loop member 32 may be secured at anydesired location along the second wave form structure 28 b.

FIG. 5 provides a perspective illustration of a trachea stent 40 havinga first end 42 and a second end 44. The trachea stent 40 has an innersurface 46 defining a lumen 48 and an outer surface 50. In someembodiments, as illustrated, the outer surface 50 includes a pluralityof spacer fins 52 that extend above the outer surface 50. In someembodiments, the spacer fins 52 are formed of a different material. Insome embodiments, the spacer fins 52 are formed of a biodegradable orbioabsorbable material that will break down or dissolve over time onceimplanted. Accordingly, the spacer fins 52 may provide migrationresistance upon implantation of the trachea stent 40 within a bodylumen. Over time, the spacer fins 52, which are formed of abiodegradable or bioabsorbable material, will break down or dissolveonce implanted. Thereafter, if it is desired to remove the trachea stent40 at a later time, the degradation or absorption of the spacer fins 52will reduce the trauma experienced by the patient in removing thetrachea stent 40 from the body lumen.

Illustrative but non-limiting examples of suitable biodegradable orbioabsorbable materials include polymers, such as poly-L-lactide (PLLA),polyglycolide (PGA), polylactide (PLA), poly-D-lactide (PDLA),polycaprolactone, polydioxanone, polygluconate, polylacticacid-polyethylene oxide copolymers, modified cellulose, collagen,poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(aminoacids), and combinations thereof.

In some embodiments, the spacer fins 52 could also provide drug elution.The terms “therapeutic agents,” “drugs,” “bioactive agents,”“pharmaceuticals,” “pharmaceutically active agents”, and other relatedterms may be used interchangeably herein and include genetic therapeuticagents, non-genetic therapeutic agents, and cells. Therapeutic agentsmay be used singly or in combination. A wide range of therapeutic agentloadings can be used in conjunction with the devices of the presentinvention, with the pharmaceutically effective amount being readilydetermined by those of ordinary skill in the art and ultimatelydepending, for example, upon the condition to be treated, the nature ofthe therapeutic agent itself, the tissue into which the dosage form isintroduced, and so forth.

Some specific beneficial agents include anti-thrombotic agents,anti-proliferative agents, anti-inflammatory agents, anti-migratoryagents, agents affecting extracellular matrix production andorganization, antineoplastic agents, anti-mitotic agents, anestheticagents, anti-coagulants, vascular cell growth promoters, vascular cellgrowth inhibitors, cholesterol-lowering agents, vasodilating agents, andagents that interfere with endogenous vasoactive mechanisms.

More specific drugs or therapeutic agents include paclitaxel, sirolimus,everolimus, tacrolimus, Epo D, dexamethasone, estradiol, halofuginone,cilostazole, geldanamycin, ABT-578 (Abbott Laboratories), trapidil,liprostin, Actinomcin D, Resten-NG, Ap-17, abciximab, clopidogrel,Ridogrel, beta-blockers, bARKct inhibitors, phospholamban inhibitors,and Serca 2 gene/protein, resiquimod, imiquimod (as well as otherimidazoquinoline immune response modifiers), human apolioproteins (e.g.,AI, AII, AIII, AIV, AV, etc.), vascular endothelial growth factors(e.g., VEGF-2), as well as derivatives of the forgoing, among manyothers.

Numerous additional therapeutic agents useful for the practice of thepresent invention may be selected from those described in paragraphs[0040] to [0046] of commonly assigned U.S. Patent Application Pub. No.2003/0236514, the entire disclosure of which is hereby incorporated byreference.

While the spacer fins 52 are illustrated as being generally alignedalong an axial length of the trachea stent 40 (i.e., generally parallelto a central longitudinal axis of the trachea stent 40), it will beappreciated that in some embodiments, the spacer fins 52 could bealigned perpendicular or at an acute angle relative to an axial lengthof the trachea stent 40 (i.e., generally non-parallel to a centrallongitudinal axis of the trachea stent 40, such as perpendicular to orat an acute angle to the central longitudinal axis of the trachea stent40), in order to limit migration in a particular direction, for example.Moreover, while the spacer fins 52 are shown as being generallytriangular in shape, it will be appreciated that in some cases thespacer fins 52 may have other shapes, such as round or square.

FIG. 6 provides a schematic cross-sectional view of the trachea stent40, illustrating that the trachea stent 40 may, in some embodiments,include an expandable metal structure 54 and a polymeric coating orsleeve 56 disposed over the expandable metal structure 54. Theexpandable metal structure 54 is generically illustrated, as theexpandable metal structure 54 may have any desired design andconfiguration. For example, in some embodiments, the expandable metalstructure 54 may represent a laser cut structure that can be laser cutfrom a tube. In some embodiments, the expandable metal structure 54 mayrepresent a wound metal structure. In some embodiments, the expandablemetal structure 54 may represent a braided metal structure. In someembodiments, as shown in FIG. 6, the spacer fins 52 may be securedrelative to the trachea stent 40 by encapsulating the spacer fins 52within the polymeric coating or sleeve 56. In some embodiments, thespacer fins 52 may have a base and an opposing apex positioned radiallyoutward from the base, and the base of each of the spacer fins 52 may beencapsulated within the polymeric coating or sleeve 56 and the apex ofeach of the spacer fins is exposed from and extends radially outwardfrom the polymeric coating or sleeve 56 such that the biodegradablematerial forming the spacer fins 52 are exposed after implantation.

In some embodiments, the spacer fins 52 may be formed by placing abiodegradable cap directly on a portion of the expandable metalstructure 54. As schematically illustrated in FIG. 7, an expandablemetal structure 54 a may include high spots 54 b, such as an apex of astent strut. A spacer fin 52 a may be formed by securing a biodegradablecap 52 b onto the high spot 54 b or protruding portion of the expandablemetal structure 54 a. In some embodiments, while not illustrated, apolymeric covering or sleeve could cover the expandable metal structure54 a prior to securing the biodegradable cap 52 b onto the high spot 54b or protruding portion.

Another method for creating the spacer fins 52 is illustrated in FIG. 8,which shows a schematic cross-sectional view of an expandable metalstructure 54 c. As discussed above with respect to the expandable metalstructure 54, the expandable metal structure 54 c may genericallyrepresent a laser cut structure, a wound structure or a braided metalstructure. A filament 58 may be wrapped around the expandable metalstructure 54 c, in and out of apertures formed within the expandablemetal structure 54 c such that the filament 58 forms high spots 60 orradially outwardly protruding portions. The high spots 60 or protrudingportions may form spacer fins. While a single filament 58 is shown, itwill be appreciated that a plurality of filaments 58 may be wrappedaround the expandable metal structure 54 c. The filament 58 may beformed of any desired biodegradable or bioabsorbable material, asdiscussed above with respect to the spacer fins 52, and may have anydesired diameter such as about 0.5 cm.

In some embodiments, as noted, the expandable metal structure 54, 54 band 54 c may be cut from a metal tube using any desired technique,including but not limited to micro-machining, saw-cutting (e.g., using adiamond grit embedded semiconductor dicing blade), electron dischargemachining, grinding, milling, casting, molding, chemically etching ortreating, or other known methods, and the like. Some example embodimentsof appropriate micromachining methods and other cutting methods, andstructures for tubular members including slots and medical devicesincluding tubular members are disclosed in U.S. Pat. Publication Nos.2003/0069522 and 2004/0181174-A2; and U.S. Pat. Nos. 6,766,720; and6,579,246, the entire disclosures of which are herein incorporated byreference. Some example embodiments of etching processes are describedin U.S. Pat. No. 5,106,455, the entire disclosure of which is hereinincorporated by reference.

In at least some embodiments, a laser cutting process may be used. Thelaser cutting process may include a suitable laser and/or laser cuttingapparatus. For example, the laser cutting process may utilize a fiberlaser. Utilizing processes like laser cutting may be desirable for anumber of reasons. For example, laser cutting processes may allow for anumber of different cutting patterns in a precisely controlled manner.Furthermore, changes to the cutting pattern can be made without the needto replace the cutting instrument (e.g., blade).

The materials that can be used for the expandable metal structure 54, 54b, 54 c may include those commonly associated with medical devices. Forsimplicity purposes, the following discussion makes reference to theexpandable metal structure 54. However, this is not intended to limitthe devices and methods described herein, as the discussion may beapplied to other similar structures.

The expandable metal structure 54, 54 b, 54 c, may be made from a metal,metal alloy, polymer (some examples of which are disclosed below), ametal-polymer composite, ceramics, combinations thereof, and the like,or other suitable material. Some examples of suitable metals and metalalloys include stainless steel, such as 304V, 304L, and 316LV stainlesssteel; mild steel; nickel-titanium alloy such as linear-elastic and/orsuper-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;combinations thereof; and the like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear that the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also can be distinguished based on its composition),which may accept only about 0.2 to 0.44 percent strain beforeplastically deforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Some examples of nickel titanium alloys aredisclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which areincorporated herein by reference. Other suitable materials may includeULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available fromToyota). In some other embodiments, a superelastic alloy, for example asuperelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the trachea stents 20and 40 described herein may also be doped with, made of, or otherwiseinclude a radiopaque material. Radiopaque materials are understood to bematerials capable of producing a relatively bright image on afluoroscopy screen or another imaging technique during a medicalprocedure. Some examples of radiopaque materials can include, but arenot limited to, gold, platinum, palladium, tantalum, tungsten alloy,polymer material loaded with a radiopaque filler, and the like.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the trachea stents 20, 40. For example,the trachea stents 20, 40, or portions thereof, may be made of amaterial that does not substantially distort the image and createsubstantial artifacts (e.g., gaps in the image). Certain ferromagneticmaterials, for example, may not be suitable because they may createartifacts in an MRI image. Trachea stents 20, 40, or portions thereof,may also be made from a material that the MRI machine can image. Somematerials that exhibit these characteristics include, for example,tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such asELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenumalloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, andthe like, and others.

As noted, the trachea stents 20, 40 may include a sheath or coveringthereover. Suitable polymeric material include but are not limited topolytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE),fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like.

In some embodiments, the exterior surfaces of the expandable metalstructures 22, 52 may be sandblasted, beadblasted, sodiumbicarbonate-blasted, electropolished, etc. In these as well as in someother embodiments, a coating, for example a lubricious, a hydrophilic, aprotective, or other type of coating may be applied thereover portions.Alternatively, the expandable metal structures 22, 52 may include alubricious, hydrophilic, protective, or other type of coating.Hydrophobic coatings such as fluoropolymers provide a dry lubricitywhich improves guidewire handling and device exchanges. Lubriciouscoatings improve steerability and improve lesion crossing capability.Suitable lubricious polymers are well known in the art and may includesilicone and the like, hydrophilic polymers such as high-densitypolyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides,polyvinylpyrrolidones, polyvinylalcohols, hydroxy alkyl cellulosics,algins, saccharides, caprolactones, and the like, and mixtures andcombinations thereof. Hydrophilic polymers may be blended amongthemselves or with formulated amounts of water insoluble compounds(including some polymers) to yield coatings with suitable lubricity,bonding, and solubility. Some other examples of such coatings andmaterials and methods used to create such coatings can be found in U.S.Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein byreference.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A medical stent extending from a first end to asecond end, the medical stent comprising: an expandable metal structureextending from the first end to the second end, the expandable metalstructure convertible between a compressed configuration for deliveryand an expanded configuration once deployed, the expandable metalstructure including an inner surface defining a stent lumen and an outersurface; and a plurality of spacer fins extending above the outersurface of the expandable metal structure; wherein the plurality ofspacer fins are formed of a material different than that of theexpandable metal structure.
 2. The medical stent of claim 1, wherein theplurality of spacer fins are formed of a biodegradable or bioabsorbablematerial.
 3. The medical stent of claim 2, wherein the plurality ofspacer fins include a therapeutic agent.
 4. The medical stent of claim1, further comprising a polymer coating disposed over the expandablemetal structure.
 5. The medical stent of claim 4, wherein a base of eachof the plurality of spacer fins is encapsulated within the polymercoating and an apex of each spacer fin is exposed radially above thepolymer coating.
 6. The medical stent of claim 4, wherein the pluralityof spacer fins are separately formed with each having an end, and theends of the plurality of spacer fins are encapsulated in the polymercoating.
 7. The medical stent of claim 1, wherein the plurality ofspacer fins comprise a cap secured to high spots formed within theexpandable metal structure.
 8. The medical stent of claim 7, wherein thecap is biodegradable or bioresorbable.
 9. The medical stent of claim 7,wherein the expandable metal structure is formed from a plurality ofstruts, wherein each high spot is an apex of a stent strut.
 10. Themedical stent of claim 1, wherein the plurality of spacer fins arealigned parallel to a longitudinal axis of the expandable metalstructure.
 11. The medical stent of claim 1, wherein the plurality ofspacer fins are formed from a filament that is interlaced within theexpandable metal structure.
 12. The medical stent of claim 11, whereinthe expandable metal structure is cut from a metal tube and theplurality of spacer fins are formed from the filament extending in andout of apertures in the expandable metal structure, wherein the filamentforms high spots protruding radially outward from the metal tube. 13.The medical stent of claim 11, wherein the filament is biodegradable orbioresorbable.
 14. A medical stent extending from a first end to asecond end, the medical stent comprising: an expandable metal structureextending from the first end to the second end, the expandable metalstructure convertible between a compressed configuration for deliveryand an expanded configuration once deployed, the expandable metalstructure including an inner surface defining a stent lumen and an outersurface, wherein the expandable metal structure is formed from aplurality of struts; and a plurality of high spots extending above theouter surface of the expandable metal structure, each high spot formedat an apex of a strut; a plurality of caps secured to the plurality ofhigh spots, the plurality of caps forming spacer fins, wherein the capsare formed of a material different than that of the expandable metalstructure.
 15. The medical stent of claim 14, wherein the caps arebiodegradable or bioresorbable.
 16. The medical stent of claim 14,further comprising a polymer coating disposed over the expandable metalstructure.
 17. The medical stent of claim 16, wherein a base of each ofthe plurality of spacer fins is encapsulated within the polymer coatingand an apex of each spacer fin is exposed radially above the polymercoating.
 18. The medical stent of claim 14, wherein the plurality ofspacer fins are aligned parallel to a longitudinal axis of theexpandable metal structure.
 19. The medical stent of claim 11, whereinthe expandable metal structure is cut from a metal tube and theplurality of spacer fins are formed from a filament extending in and outof apertures in the expandable metal structure, wherein the filamentforms the high spots protruding radially outward from the metal tube.20. A medical stent extending from a first end to a second end, themedical stent comprising: an expandable metal structure extending fromthe first end to the second end, the expandable metal structureconvertible between a compressed configuration for delivery and anexpanded configuration once deployed, the expandable metal structureincluding an inner surface defining a stent lumen and an outer surface;a plurality of spacer fins extending above the outer surface of theexpandable metal structure; and a polymer coating disposed over theexpandable metal structure; wherein the plurality of spacer fins areformed of a material different than that of the expandable metalstructure; wherein a base of each of the plurality of spacer fins isencapsulated within the polymer coating and an apex of each spacer finis exposed radially above the polymer coating.